H2O VR for Burns 2015 (H2OWC)

• ClinicalTrials.gov Identifier: NCT02729259
• Recruitment Status: Completed
• First Posted: April 6, 2016
• Last Update Posted: June 9, 2020
• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Collaborator: University of Washington
• Information provided by (Responsible Party): David R. Patterson, National Institute of General Medical Sciences (NIGMS)

Study Description

Brief Summary:

This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

Condition or disease	Intervention/treatment	Phase
Pain; Burn	Behavioral: Virtual Reality Snowworld; Behavioral: Virtual Reality slides of nature; Behavioral: Control standard nurse wound care	Not Applicable

Detailed Description:

This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Other
• Official Title: Water Friendly Virtual Reality for Burns
• Actual Study Start Date: October 2015
• Actual Primary Completion Date: June 2020
• Actual Study Completion Date: June 2020

Arms and Interventions

Arm	Intervention/treatment
Virtual Reality Snowworld; The subjects will receive Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.	Behavioral: Virtual Reality Snowworld; The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.
Virtual Reality slides of nature; The subjects will see several slides of the nature through virtual reality goggles during their wound care. The nurse will be doing the wound care.	Behavioral: Virtual Reality slides of nature; The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.
Control standard nurse wound care; The subjects will receive their standard care during wound care. The nurse will be doing the wound care.	Behavioral: Control standard nurse wound care; The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

Outcome Measures

Primary Outcome Measures :

1. "Pain and anxiety" as measured by Graphic Rating Scale [ Time Frame: up to an hour ]
   Pain and anxiety is being measured

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years
• Compliant and able to complete questionnaires
• No history of psychiatric disorder
• Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
• Able to communicate verbally
• English-speaking

Exclusion Criteria:

• Age less than 18 years
• Not capable of indicating pain intensity
• Not capable of filling out study measures
• Evidence of traumatic brain injury
• History of psychiatric disorder
• Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
• Unable to communicate orally
• Receiving prophylaxis for alcohol or drug withdrawal
• Developmental disability
• Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
• Non-English Speaking
• Extreme susceptibility to motion sickness
• Seizure history

Contacts and Locations

Locations

United States, Washington

Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of General Medical Sciences (NIGMS)

University of Washington

Investigators

• Principal Investigator: David R. Patterson, Ph.D.; University of Washington

More Information

• Responsible Party: David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)
• ClinicalTrials.gov Identifier: NCT02729259
• Other Study ID Numbers: 50416EB/002594
• First Posted: April 6, 2016
• Last Update Posted: June 9, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by David R. Patterson, National Institute of General Medical Sciences (NIGMS):

VRD

Additional relevant MeSH terms:

Burns; Wounds and Injuries